The following data is part of a premarket notification filed by Omniguide, Inc. with the FDA for Omniguide Beampath Laser Beam Delivery System.
Device ID | K062423 |
510k Number | K062423 |
Device Name: | OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM |
Classification | Powered Laser Surgical Instrument |
Applicant | OMNIGUIDE, INC. ONE KENDALL SQUARE, BLDG 100 3RD FLOOR Cambridge, MA 02139 |
Contact | Douglas W Woodruff |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2006-08-18 |
Decision Date | 2006-09-21 |
Summary: | summary |